study to compare the pharmacokinetics of dipyridamole in three different asasantin extended release (er) formulations in healthy male and female volunteers

Conditions: Healthy

Summary: comparative pharmacokinetics of dipyridamole in two new formulations of asasantin er compared to the present commercial formulation


Eligibility criteria:
inclusion criteria: * all participants in the study should be healthy males or females, range from 21 to 50 years of age and be within ± 20 % of their normal weight (broca-index) * prior to admission to the study all volunteers will have given, in accordance with good clinical practice (gcp) and the local legislation, their written informed consent * subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ecg * hematopoietic, hepatic and renal function tests will be carried out in the laboratory * the subjects will fast for 12 hours before collection of specimens for all laboratory evaluations * the above mentioned examinations will be performed within 14 days before the first administration of the test substance exclusion criteria: * volunteers are excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values * subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric or neurological disorders * history of orthostatic hypotension, fainting spells or blackouts * subjects with chronic or relevant acute infections * subjects with allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * volunteers who have taken a drug with a long half-life (≥ 24 hours) within one month or less than ten half-lives of the respective drug before enrolment in the study * volunteers who receive any other drugs which might influence the results of the trial during the week previous to enrolment in the study * volunteers who participate in another study with an investigational drug within the last two months preceding the study * volunteers who are unable to refrain from smoking on study days * volunteers who smoke more than10 cigarettes (or equivalent) per day * volunteers who drink more than 60 g of alcohol per day * volunteers who are dependent on drugs * volunteers who donate blood (≥ 100 ml) within the last four weeks * volunteers who participate in excessive physical activities within the last week before the study (e.g. competitive sports) * volunteers who suffer from any other disease or abnormality of clinical relevance * history of hemorrhagic diatheses * history of gastro-intestinal ulcer, perforation or bleeding * history of bronchial asthma * history of glucose-6-phosphate dehydrogenase (g-6-pd) deficiency female subjects: * pregnancy * positive pregnancy test * no adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (iud), oral contraceptives) * inability to maintain this adequate contraception during the whole study period * lactation period